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A significant concern in the healthcare sector is the potential conflict of interest between the pharmaceutical and medical products industry and healthcare professionals, particularly physicians. This potential conflict arises from the unique nature of the relationship: while the industry’s end customer is the patient, it is the physician who decides which product the patient will use. At the same time, patients pay physicians to prescribe the best treatment for their well-being.
When the pharmaceutical or medical products industry provides personal benefits to physicians, potentially influencing their autonomy in prescribing the most appropriate treatment, a conflict of interest arises. These benefits can range from simple gifts, such as pens, to all-expense-paid trips abroad. Another method of offering benefits is through hiring physicians for specific services.
Today, with many competing products that have similar efficacy and safety profiles in most therapeutic areas, a physician's recommendation of a particular product – after receiving financial support from the industry – may not directly harm the patient's health. However, this does not eliminate the conflict of interest, as a physician’s decision should be based solely on the transparent presentation of the product's value to patient health, without external influence.
Physician Payments Sunshine Act
The Physician Payments Sunshine Act (commonly known as the Sunshine Act) is a U.S. law enacted in 2010 as part of the Affordable Care Act. Its primary goal is to enhance transparency around payments and other transfers of value made by pharmaceutical companies and healthcare product manufacturers to physicians and hospitals.
This legislation was the first of its kind to address transparency in the relationship between the industry and physicians. It mandates that companies submit an annual report to the U.S. government detailing payments or transfers of value made to physicians and hospitals, including fees for lectures, consulting, travel, meals, or gifts. The data is published annually in a public database managed by the Centers for Medicare and Medicaid Services (CMS), known as Open Payments. This allowed the public to see which physicians and healthcare institutions receive funds from pharmaceutical or medical product companies.
The law's intent is to shed light on potential conflicts of interest, enabling patients to make informed decisions when choosing a healthcare provider.
Disclosure Code – EFPIA
In Europe, the regulation of the relationship between the pharmaceutical industry and healthcare professionals was initially governed not by law but by the Disclosure Code, published by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This self-regulatory code addressed the need for transparency regarding value transfers from the industry to healthcare professionals, particularly physicians, in response to potential conflicts of interest.
Following the implementation of the Disclosure Code, several European countries introduced specific laws to ensure transparency in these transactions, including France, Slovakia, Portugal, Greece, Denmark, and others. For a more in-depth exploration of this topic, the article “Capturing Value Transfers for Healthcare Professionals” is highly recommended
The Brazilian Context
In Brazil, only the State of Minas Gerais has made significant progress in addressing this issue through the enactment of specific laws. These include:
By enacting these two laws, Minas Gerais requires the healthcare industry to document all transfers of value made to healthcare professionals registered with councils in the state, as well as sponsorships organized by companies from Minas Gerais in other states. Additionally, the industry must submit an annual report to the Minas Gerais State Health Department by the last day of January of the following year.
In a similar vein, several federal bills have been proposed: Bill #7,990/2017, introduced on April 7, 2017, by Representative Geraldo Resende (PSDB-MT); Bill #11,050/2018, introduced on November 27, 2018, by Representative Carlos Henrique Gaguim (DEM-GO); Bill #11,177/2018, introduced on December 11, 2018, by Representative Reginaldo Lázaro de Oliveira Lopes (PT-MG); and Bill #204/2019, introduced on February 4, 2019, by Representative Roberto de Lucena (Podemos-SP). These bills aim to make the Ministry of Health and Anvisa (the Brazilian FDA) responsible for receiving and disseminating such information across all states. Exception of the third bill, which only mentions the Ministry of Health. However, none of these bills have been enacted into law as of yet.
Brazilian Medical Association Issues Rule #2386 of August 21, 2024
On August 21, 2024, the Brazilian Medical Association issued Rule #2386. Published in the Federal Gazette on September 2, 2024, this Rule sets forth rules and procedures regarding physicians' relationships with the pharmaceutical, healthcare supplies, and medical equipment industries. However, this standard has a delayed effective date of 180 days and, therefore, comes into force only 180 days after the date of its publication.
According to this rule, physicians with ties to pharmaceutical companies, medical product manufacturers, or suppliers of equipment for exclusive or common medical use must inform the Regional Medical Association where they are registered, via the “CRM-Virtual” website, about the company(ies) with which they are associated. Physicians are also required to notify the council when these relationships end.
This new regulation differs significantly from other standards in two key ways: it does not require the publication of specific values, and it delegates the responsibility for disclosure to the “CRM-Virtual” websites of the Regional Medical Association in each state. By contrast, in the United States, under the Physician Payments Sunshine Act, the Centers for Medicare and Medicaid Services (CMS) coordinates publication. In Europe, under the Disclosure Code, pharmaceutical companies are responsible for publishing data on their websites. In Minas Gerais, the State Health Department handles publication via its Declarasus platform.
The rule defines what constitutes a professional tie:
I – Formal employment related to the pharmaceutical industry or companies that produce medical products, supplies, or equipment for exclusive medical use or common use across professions, or those acting as intermediaries in the sale of such products.
II – Occasional and/or paid services provided to these industries.
III – Participation in research or development of drugs, materials, products, or equipment for exclusive or shared medical use.
IV – Invitations or paid engagements to promote products or services.
V – Membership in the Brazilian Committee for Health Technology Incorporation (Conitec) or other similar bodies such as the Brazilian Supplementary Health Agency (ANS) and Anvisa.
VI –Serving as a keynote speaker.
Physicians who receive any such benefits must now report them within 60 days of receipt, also being required to declare any potential conflicts of interest during interviews, debates, or medical conferences. Exceptions to these reporting obligations include: (i) income and dividends from investments in shares or participation quotas in the benefactor companies, (ii) free samples of medicines or products received, and (iii) benefits received by scientific societies and medical associations.
Finally, the resolution explicitly prohibits physicians from accepting benefits related to medications, orthoses, prostheses, special materials, or hospital equipment that are not registered with Anvisa. The only exception is for research protocols approved by Research Ethics Committees.
Practical Impact on Society
The goal of this initiative by the Brazilian Medical Association, along with similar efforts by governments and professional associations, is to prevent physicians from being influenced by personal benefits offered by healthcare industries in exchange for prescribing certain products. The aim is to ensure that physicians are not swayed by financial incentives to favor particular prescriptions in return for investments made by these industries.
Ideally, companies should focus on investing in new products and improving production quality, promoting them based on the value they provide to patients. However, the market is diverse, and not all pharmaceutical companies, for example, are involved in developing new products. This is partly due to the immense resources required to create a new drug.
I recall attending a seminar where the CEO of a major company, who was also a speaker, shared an insightful remark: “Marketing a new product that’s just hit the market is easy. But how do you market Merthiolate to a physician? What else can you tell them that they don’t already know?” Evidently, Merthiolate was used as an example of a mature product that has been on the market for a long time, illustrating the challenge of promoting well-known, established products.
Another important consideration is the patient. Despite these commendable initiatives, most patients are unaware of them, and even those who are informed rarely take the time to investigate potential conflicts of interest when selecting a physician. As a result, the effort to increase transparency may be in vain. Without public awareness campaigns, these initiatives, though valuable, are unlikely to achieve their desired impact.
